FDA.reportPublic FDA data

Quetiapine

Product NDC
68180-616
11-digit product format
681800616
Labeler code
68180
Product ID
68180-616_486bd7e7-86bb-44cb-98fc-33584ddcfe98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA204203
Marketing category
ANDA
Marketing start
2017-08-22
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 853201, 895670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-616-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10020
68180-616-07Quetiapine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-616-07EA - Each68180-6165a361b4d-06a6-4d4a-b00e-27771e33d51912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-616QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20231216_7803a290-91c0-4e7f-90b5-d2ff33a46cee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN7803a290-91c0-4e7f-90b5-d2ff33a46cee20
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN7803a290-91c0-4e7f-90b5-d2ff33a46cee20
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD7803a290-91c0-4e7f-90b5-d2ff33a46cee20
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD7803a290-91c0-4e7f-90b5-d2ff33a46cee20
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD7803a290-91c0-4e7f-90b5-d2ff33a46cee20
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD7803a290-91c0-4e7f-90b5-d2ff33a46cee20
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD7803a290-91c0-4e7f-90b5-d2ff33a46cee20
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY7803a290-91c0-4e7f-90b5-d2ff33a46cee20
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSNb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCDb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSYb02324b1-e7f0-4cbc-8778-5f7c4a5d194a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-616-0168180061601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-616-01) 2017-08-220000-00-00NoNoCurrent
68180-616-076818006160760 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-616-07) 2017-08-220000-00-00NoNoCurrent